Pfizer to Ask FDA to Allow Booster Shots for ages 5-11

Pfizer to Ask FDA to Allow Coronavirus Booster Shots for Kids 5-11

 

April 14, during a Press release Pfizer said that the company along with its partner firm BioNTech said it will submit an application to the Food and Drug Administration for emergency use authorization in the “coming days.”

  • Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine
  • In the Phase 2/3 clinical trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by 6-fold against the SARS-CoV-2 wild-type strain in this age group
  • Companies plan to submit these data to U.S. Food and Drug Administration in the coming days with additional submissions to other regulatory agencies worldwide to follow

A third shot is already recommended for people ages 12 and older, and FDA recently offered a second booster shot to Americans ages 50 and older.

Pfizer and BioNTech plan to submit a request for Emergency Use Authorization (EUA) of a booster dose for children ages 5 through 11 in the U.S. in the coming days. The companies also plan to share these data with the European Medicines Agency (EMA) and other regulatory agencies around the world as soon as possible.

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